How to design successful clinical trials and meet enrollment goals

Clinical trial enrollment hasn't gotten easier

In 2023, recruiting patients for clinical trials can still be daunting and difficult. 46% of clinical trials fail to meet their enrollment criteria, and 11% fail to recruit even a single patient while 37% of trials under recruit. While there are many potential reasons for why trials may fail to reach their enrollment targets, poor clinical trial design is one of the biggest culprits. Strong clinical trial design (designing a trial that is recruitable, with a large enough pool of potentially eligible patients) is a foundational factor to enrollment success. 

Studies usually discover clinical trial design issues too late

Unfortunately, many studies find out their inclusion and exclusion criteria choices are too restrictive after recruitment is well under way and patient screen failure rates are high. This presents a challenging and costly scenario in which screen failure rates are high, protocols may need to be amended, and cost and time of patient recruitment become prohibitive.

Evaluating trial feasibility before enrollment saves time and money

To avoid these issues, it is essential to design the study carefully and evaluate its feasibility before launching the clinical trial. This includes finding the balance between scientifically optimal and recruitable inclusion and exclusion criteria for participants, estimating the target population size, and determining if it is possible to recruit the desired number of patients within the target enrollment timeline and given the available funding. 

A data driven approach

Partnering with an experienced third party during the clinical trial design phase can save millions of dollars in future costs. Trials.Co’s approach sets our manufacturer partners up for success by utilizing data from past and current trial recruitments, anonymized patient records, and our KOL network of clinicians to create the most accurate forecast and projection of enrollment for a clinical trial. This projection enables partners to approach the recruitment phase with data-driven confidence.

Trials.Co’s clinical trial design solution:

• Utilizes a team of expert data scientists, machine learning engineers, research scientists, and clinicians with clinical trials expertise
• Conducts top-down funnel analyses to identify potentially restrictive criteria before a study starts, by evaluating each inclusion and exclusion criteria with the help of both clinical data and our panel of KOL clinicians. This allows study sponsors to begin enrollment with more confidence that the target population of patients can be identified and enrolled.
• Streamlines the pre-screening and screening processes by collaborating with Clinical Operations teams to review and optimize the protocol, resulting in more efficient, cost-effective, and smoother patient enrollment for all parties involved - patients, sites, and study sponsors.
• Offers cost projections for the full patient recruitment process.